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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K253946
Device Name Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd.
Bantian St., Longgang
Shenzhen,  CN 518129
Applicant Contact Caitlin Liang
Correspondent
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd.
Bantian St., Longgang
Shenzhen,  CN 518129
Correspondent Contact Caitlin Liang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/10/2025
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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